RCT_ECOG 2002

Trial name or title	Randomised Chemoprevention Study of Selenium in Participants With Previously Resected Stage I Non‐Small Cell Lung Cancer
Methods	Randomised controlled trial
Participants	Disease characteristics: Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non–small‐cell lung cancer (except carcinoid) Completion of treatment for stage I lung cancer within the past six to 36 months and currently disease free At least one mediastinal lymph node sampled at resection Age: 18 years and older Performance status: ECOG zero to one A total of 1960 participants (980 per arm) will be accrued for this study within four years
Interventions	Arm I: Participants receive oral selenium yeast daily for six months. Treatment repeats every six months for eight courses for a total of four years in the absence of unacceptable toxicity Arm II: Participants receive an oral yeast placebo as in arm I Participants are followed annually
Outcomes	Second incidence/recurrence of primary lung tumours Toxicity Incidence of specific cancers, mortality from cancer and overall survival
Starting date	October 2000
Contact information	Eastern Cooperative Oncology Group Daniel Karp, MD, Protocol chair Phone: 713‐745‐7398; 800‐392‐1611 Southwest Oncology Group Omer Kucuk, MD, Protocol chair Phone: 313‐576‐8739; 800‐527‐6266 Email: kucuko@karmanos.org
Notes	Recruiting